Sever Pharma Solutions is a contract developer and manufacturer specializing in high-potency pharmaceuticals. The headquarters in Malmö has been developing and manufacturing pharmaceuticals for almost 50 years according to the high demands placed on pharmaceutical companies. Our customers range from large global to smaller pharmaceutical companies and we have over 340 employees in Malmö and the USA. For more information about the company, see our website www.severpharmasolutions.com

Would you like to be part of a dynamic team working with state-of-the-art process equipment in an environment characterized by high degree of freedom and responsibility?

About the position
We are seeking a highly skilled and motivated Senior Technical Process Engineer to join our dynamic team. In this role, you will lead and support a variety of technical projects focused on equipment and process development within a regulated pharmaceutical manufacturing environment. Your expertise will be crucial in driving innovation, ensuring compliance, and enhancing operational efficiency.

Key Responsibilities

• Lead feasibility studies, efficiency improvements, and upgrade projects from a technical perspective.
• Act as a technical expert in cross-functional teams for product development and production improvement initiatives.
• Manage the procurement, implementation, and qualification of equipment across various projects.
• Conduct technical testing and qualification of equipment.
• Drive the development of requirement specifications including:

• URS (User Requirement Specifications)
• FAT (Factory Acceptance Testing)
• SAT (Site Acceptance Testing)
• Qualification protocols and risk assessments

Skills & Qualifications
We are looking for an experienced Engineer with the following profile:

• Proven experience in equipment-related projects within GMP-regulated environments.
• Strong understanding of regulatory frameworks including:

• EU-GMP
• ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients)
• GAMP 5 (Risk-Based Approach to GxP Computerized Systems)
• Polymer Extrusion and Welding
• Aseptic Manufacturing
• Containment Technologies

• Ability to work independently and collaboratively in cross-functional teams.
• Excellent problem-solving and communication skills.
• Meritorious Knowledge

Company Values

SEVER's values are important to us, and it is therefore important that you also share them:

• Making a difference

• With the world in focus
• Scientific
• Quality
• Personal Development
• Respect and honesty
• Responsibility and consideration
• Long-term relationships
• Create value
• Flexibility

• Best workplace

• Close to the customer

Why Sever Pharma Solutions?
You’ll be part of a forward-thinking organization where your technical expertise will directly contribute to the development of life-saving products. We offer a collaborative work environment, opportunities for professional growth, and the chance to make a real impact.

Information and application
For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Sever, please visit: www.severpharmasolutions.com/.

We are looking forward to seeing your application!